BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC TRANSCATHETER VALVE

    MDR report key: 20951467 · Received December 17, 2024

    Report

    Report Number
    2025587-2024-07370
    Event Type
    Injury
    Date Received
    December 17, 2024
    Date of Event
    November 20, 2024
    Report Date
    December 17, 2024
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: REKHTMAN, D, IYENGAR, A, HAN, J. ET AL. TRANSCATHETER AORTIC VALVE REPLACEMENT EXPLANT IN THE SETTING OF A PORCELAIN AORTA. J AM COLL CARDIOL CASE REP. 2024 NOV, 29 (22). HTTPS://DOI.ORG/10.1016/J.JACCAS.2024.102732 EARLIEST DATE OF PUBLICATION USED FOR DATE OF EVENT. THE MEDTRONIC ¿23-MM EVOLUT VALVE¿ MENTIONED IN THE ARTICLE MAY HAVE BEEN AN EVOLUT R (PRODUCT CODE NPT, PMA# P130021), EVOLUT PRO (PRODUCT CODE NPT, PMA# P130021), EVOLUT PRO+ (PRODUCT CODE NPT, PMA# P130021), OR EVOLUT FX (PRODUCT CODE NPT, PMA# P130021). EARLIEST APPROVED PRODUCT USED FOR PRODUCT CODE AND PMA#. NO UNIQUE DEVICE IDENTIFIER (SERIAL/LOT) NUMBERS WERE PROVIDED; WITHOUT THIS INFORMATION IT COULD NOT BE DETERMINED WHETHER THESE OBSERVATIONS HAVE BEEN PREVIOUSLY REPORTED. WITHOUT RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATIONS. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    LITERATURE WAS REVIEWED REGARDING A PATIENT WHO PREVIOUSLY UNDERWENT TRANSCATHETER AORTIC VALVE REPLACEMENT WITH A MEDTRONIC 23 MM EVOLUT VALVE. APPROXIMATELY EIGHTEEN MONTHS LATER, THE PATIENT WAS REFERRED TO THE AUTHORS FOR SEVERE MITRAL VALVE STENOSIS AND WAS FOUND TO HAVE PATIENT-PROSTHESIS MISMATCH (PPM) OF THE EVOLUT VALVE DUE TO INSUFFICIENT EXPANSION OF THE VALVE FRAME CAUSED BY THE PATIENT¿S CALCIFIED AORTA. THE PATIENT EXPERIENCED DYSPNEA, CHEST PAIN, PRE-SYNCOPE, AND 3-PILLOW ORTHOPNEA LEADING UP TO THE DIAGNOSIS OF SEVERE MITRAL STENOSIS AND PPM/INSUFFICIENT EXPANSION OF THE EVOLUT VALVE. ELEVATED GRADIENTS (MEAN 15.5 MM HG) WERE ALSO NOTED ACROSS THE EVOLUT VALVE. THE PATIENT SUBSEQUENTLY UNDERWENT A SURGICAL PROCEDURE IN WHICH THE EVOLUT VALVE WAS EXPLANTED, THE AORTIC VALVE AND ROOT WERE REPLACED WITH A 19 MM NON-MEDTRONIC MECHANICAL VALVE AND A 24 MM NON-MEDTRONIC GRAFT, AND THE MITRAL VALVE WAS REPLACED WITH A 27 MM NON-MEDTRONIC MECHANICAL VALVE. ULTIMATELY, THE PATIENT WAS SUCCESSFULLY DISCHARGED HOME SIXTEEN DAYS AFTER THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292520 MEDTRONIC TRANSCATHETER VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION MDT-TRANS VALVE

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female Required Intervention| H